Reference #: 11075
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Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
The Principal Statistical Programmer provides Statistical Programming technical leadership and support to team members. The Principal Statistical Programmer is responsible for developing all aspects of statistical programming deliverables for the analysis of clinical study data in accordance with departmental SOPs and guidelines.Delegates tasks appropriately and tracks progress. The Principal Statistical Programmer may also construct estimates of project resource requirements and timelines and routinely briefs management on accomplishments, status of projects, and any issues. In addition, the Principal Statistical Programmer will be a designated member of CTWG team in the role of lead Statistical Programmer for clinical trial(s).Essential Functions
Attend multi-disciplinary team meetings, representing the statistical programming function.
Create or review and approve statistical programming plans at study and project level.
Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.).
Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies.
Develop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies.
Assist statisticians by suggesting algorithms to address novel analysis requests.
Develop software validation procedures and test plans, as necessary.
Create and document archives of software, outputs, and analysis files.
Create and maintain department SOPs related to clinical programming.
Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.
Oversee work of internal contract programmers and external vendors.
Provide time and resource estimates for project planning.Required Knowledge, Skills, and Abilities
Minimum of 7 years of experience in developing software for clinical trials using the SAS system.
Skilled in programming with SAS. Knowledge of additional programming languages a plus.
Good knowledge of statistics and Oncology drug development process.
Experience as a lead programmer for NDAs/BLAs.
Experience overseeing the work of internal contractors and external vendors (CROs).
Experience in pharmacokinetics/pharmacodynamics modeling a plus.
Familiarity with CDISC standards, including SDTM and ADaM models.
Solid verbal and written communication skills.Required/Preferred Education and Licenses
Bachelor's Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; Master's Degree preferred.FOR CANADA-BASED CANDIDATES ONLY
Jazz Pharmaceuticals Canada, Inc. and Celator Pharmaceuticals Corp. are committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive.
For this role, the full and complete base pay range is $112,000-$168,000. Individual co pensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual pay decisions. This range will be reviewed on a regular basis.
At Jazz/Celator, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, Extended Health Care, Dental, Long Term Disability, Life Insurance, RRSP, and paid vacation.Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
